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510(k) Data Aggregation

    K Number
    K140470
    Device Name
    OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER
    Manufacturer
    OBERON GMBH FIBER TECHNOLOGIES
    Date Cleared
    2014-10-15

    (232 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    OBERON GMBH FIBER TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OBERON, laser surgery fiber, Side Fire laser surgery fibers are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The OBERON laser surgery fiber is intended for use with any cleared surgical laser with a SMA 905 connector. The OBERON laser surgery fibers are indicated for use in general surgery applications for: incision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. (Diode Laser 532nm- 2100mm) OBERON laser surgery fiber is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, 1.44YAG and Diode Lasers (532mm - 2100mm) with peak and continuous power from 1-100 Watt. OBERON laser surgery fibers are indicated for use in general surgery, urology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
    Device Description
    OBERON's laser surgery fiber contains the same components and the same technological characteristics as the predicate devices. The fiber core and cladding or fibers with no cladding are made from silica which is the same material used in all the predicate devices. As mentioned, the optical fiber is made out of silica with a coaxially mounted protective sheath. The fiber distal tip can be several configurations and the fiber can be also used with hand pieces.
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